自助验配与专业验配助听器的比较：随机对照试验的系统评价与荟萃分析。

文献信息

中文摘要

背景： 成人听力损失很常见，但由于传统基于听力师验配模式中的系统性和经济性障碍，助听器的使用率仍然不足。非处方（OTC）和自助验配策略的出现提高了可及性，使用户能够独立选择并调整其设备。然而，人们仍担心减少专业参与可能会影响电声准确性、噪声下言语识别结果以及整体患者满意度。
方法： 截至2026年6月1日，对PubMed、Web of Science、CENTRAL、Scopus和Embase进行了全面文献检索。纳入比较自助验配与专业验配的平行组和交叉随机对照试验（RCT）。主要结局为患者报告的听力获益。采用随机效应模型合并标准化均数差（SMD）和风险比（RR）。
结果： 共纳入7项RCT，涉及1092名参与者。分析显示，自助验配与专业验配策略在患者报告的听力获益方面无统计学显著差异（SMD：0.01，95% CI [-0.44, 0.46]，p = 0.97，I2 = 89.2%，证据确定性极低）。同样，在次要结局方面也未观察到显著差异，包括噪声下言语识别表现（SMD：0.11，95% CI [-0.25, 0.47]；p = 0.55）、听力损失（p = 0.12）、助听器满意度（p = 0.31）、设备依从性（p = 0.65）或需要随访调整（RR：0.46，95% CI [0.12, 1.71]；p = 0.25）。安全性结局数据稀少，未显示两种验配方法之间存在统计学显著差异；然而，证据不精确且无结论性。
结论： 在无并发症的轻至中度听力损失成人中，自助验配助听器在多项患者报告和功能结局方面与专业最佳实践验配相比未显示出明确差异。然而，由于偏倚风险、显著异质性、不精确性以及试验数量少，证据确定性极低。因此，这些发现具有产生假设的性质，并提示设计良好的自助验配路径可能作为特定用户的可及替代方案具有潜力，但在推荐更广泛的临床实施之前，仍需更大规模、严谨且长期的试验。

英文摘要

Background: Adult hearing loss is common, yet hearing-aid uptake remains inadequate due to systemic and financial barriers in traditional audiologist-based fitting models. Over-the-counter (OTC) and self-fitting strategies have emerged to improve accessibility, allowing users to select and adjust their devices independently. However, concerns remain that reducing professional involvement may compromise electroacoustic accuracy, speech-in-noise outcomes, and overall patient satisfaction. Methods: A comprehensive literature search across PubMed, Web of Science, CENTRAL, Scopus, and Embase was conducted up to 1 June 2026. Parallel-group and crossover randomized controlled trials (RCTs) comparing self-fitting with professional-fitting were included. The primary outcome was patient-reported hearing benefit. Standardized mean differences (SMDs) and risk ratios (RRs) were pooled using a random-effects model. Results: Seven RCTs involving 1092 participants were included. The analysis revealed no statistically significant difference between self-fitting and professional-fitting strategies regarding patient-reported hearing benefit (SMD: 0.01, 95% CI [-0.44, 0.46], p = 0.97, I2 = 89.2%, very low certainty of evidence). Similarly, no significant differences were observed across secondary outcomes, including speech-in-noise performance (SMD: 0.11, 95% CI [-0.25, 0.47]; p = 0.55), hearing loss (p = 0.12), hearing-aid satisfaction (p = 0.31), device adherence (p = 0.65), or the need for follow-up adjustment (RR: 0.46, 95% CI [0.12, 1.71]; p = 0.25). Safety outcomes were sparse and did not demonstrate a statistically significant difference between the fitting approaches; however, the evidence was imprecise and inconclusive. Conclusions: Self-fitting hearing aids showed no clear differences from professional best-practice fitting across several patient-reported and functional outcomes in adults with uncomplicated mild-to-moderate hearing loss. However, the certainty of evidence was very low because of risk of bias, substantial heterogeneity, imprecision, and the small number of trials. These findings are therefore hypothesis-generating and suggest that well-designed self-fitting pathways may have potential as an accessible alternative for selected users, but larger, rigorous, and longer-term trials are needed before broader clinical implementation can be recommended.